German coronavirus vaccine inventor investigated

The German magazine Der Spiegel gave Winfried Stöcker, a physician and entrepreneur from the northern city of Lübeck, quite a lot of publicity in early March 2021. The report  tells the story of an ingenious inventor who developed an effective vaccine against the coronavirus in his private laboratory. He had already vaccinated about 100 volunteers with it, he told the magazine.

The vaccine showed no side effects, the report claimed. It was also apparently 97% effective in those vaccinated. This, the report stated, had been proven in serological tests. The vaccine could, reportedly, easily be produced in large quantities and it would soon be possible to vaccinate everyone in Germany.

But instead of receiving the necessary support from German regulatory authorities, they filed formal criminal charges against him. And that's how they "thwarted him," according to the Spiegel report.

So is Stöcker an unrecognized genius inventor whose work has been hampered by inflexible bureaucracy or is he an irresponsible Dr. Frankenstein? In any case, the doctor's actions have caused outrage among medical experts.

Stöcker had simply skipped countless steps mandated for the protection of patient safety, they argue. DW explains the most important points about the so-called "Lübeck vaccination."

Why should he not have administered the vaccine to volunteers?

Stöcker did not present any information on approval, study protocol and preclinical validation before administering the vaccine. It appears that the vaccine went straight from his lab to the volunteers, violating formal protocol.

The approval of drugs, including vaccines, is a complicated and lengthy process. After laboratory tests on cell cultures, it then includes toxicological tests on animals. In order to even be allowed to carry out such tests, drug manufacturers must go through elaborate approval procedures. 

The same applies to the next step towards the first clinical trials in humans in phase 1, which is then followed by the further phases of drug development. A prerequisite for each individual clinical trial is also approval from the responsible regulatory authority. In Germany, this is the Paul-Ehrlich-Institute (PEI).

A basic scientific principle that Stöcker violated is that those who manufacture drugs themselves, or even their employees, are excluded from participating in trial series as test subjects. It serves to exclude the possibility of bias on the part of test subjects and ensures the objectivity of the studies. 

It was one reason why even the inventors of the BioNTech-Pfizer vaccine had not received the vaccine themselves, as CEO Ugur Sahin told DW at the end of 2020.  Stöcker, on the other hand, boasted that he administered the vaccine to his family and staff.

As a doctor, administering an unapproved drug can be ruled to be bodily harm. It also represents a breach of the doctor's duty of care. In this respect, Stöcker may also have to face sanctions from the respective medical association.

What kind of vaccine is it?

According to Stöcker,  his vaccine is based on a "recombinant antigen that can be produced easily and cheaply in a test tube." It is comparable to existing vaccines for hepatitis A and B, he said. Since the antigen, unlike mRNA or vector vaccines, is already amplified outside the body, namely in the laboratory, "there is no need to fear an uncontrolled spread of genetic information introduced into the human organism," he argues. 

In fact, such so-called subunit vaccines  have been known for a long time and are also used, for example, against influenza or human papillomaviruses (HPV).

Stöcker's vaccine is not as unique as the Spiegel report suggests, even as a COVID-19 vaccine. One of the vaccines that are currently at an advanced stage of development is also based on this principle, namely NVX-CoV2373 from Novavax. 

This vaccine is already in the European Medicines Agency's (EMA's)  approval process. 

What are the risks to volunteers?

In a German language blog post,  Austrian veterinarian Petra Falb lists a whole series of points that Stöcker does not provide any information on but which are relevant to the safety and, above all, the health of his test subjects.

For example, Falb emphasizes that Stöcker does not comment on the question of possible contamination of his vaccine with viruses or mycoplasma - very small bacteria.

However, checking for possible contaminations is "a delicate point in vaccine development," she points out, because the antigens in the vaccine are produced in the laboratory by an expression system — usually a virus — on a cell line. And materials of animal origin are also used. If the cell line contains retroviruses, there is a risk that the vaccine could later cause cancer.

The information on additives, so-called adjuvants, in Stöcker's report is also "completely inadequate," Falb notes.

How effective is the active ingredient really?

Stöcker cannot substantiate his claim that the vaccine achieves 97% efficacy. In fact, there has not been a single published study on his vaccine in a reputable journal.

So far, he has only conducted serological tests showing that antibodies to the SARS-CoV-2 virus were produced in his trial paticipants.

However, in the context of a vaccine approval, many other aspects have to be taken into account, such as the immune response of the T-cells. 

The actual efficacy - i.e., how many of the vaccinated individuals became infected with COVID-19 in a given period after vaccination compared to a placebo group - is also crucial for approval.

Typically, this is assessed at the conclusion of phase 3 in vaccine development. But Stöcker apparently has not even passed the first in a long series of necessary steps.